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Last Updated: November 23, 2024

VORASIDENIB - Generic Drug Details


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What are the generic drug sources for vorasidenib and what is the scope of freedom to operate?

Vorasidenib is the generic ingredient in one branded drug marketed by Servier and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vorasidenib has ninety-two patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for VORASIDENIB
International Patents:92
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 6
Patent Applications: 35
DailyMed Link:VORASIDENIB at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VORASIDENIB
Generic Entry Date for VORASIDENIB*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) OR ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION FOLLOWING SURGERY INCLUDING BIOPSY, SUB-TOTAL RESECTION, OR GROSS TOTAL RESECTION
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VORASIDENIB

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Servier Bio-Innovation LLCPhase 1
Katy Peters, MD, PhDPhase 1
ServierPhase 1

See all VORASIDENIB clinical trials

US Patents and Regulatory Information for VORASIDENIB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Servier VORANIGO vorasidenib TABLET;ORAL 218784-002 Aug 6, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Servier VORANIGO vorasidenib TABLET;ORAL 218784-002 Aug 6, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Servier VORANIGO vorasidenib TABLET;ORAL 218784-002 Aug 6, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Servier VORANIGO vorasidenib TABLET;ORAL 218784-001 Aug 6, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for VORASIDENIB

Country Patent Number Title Estimated Expiration
Taiwan 201930285 Cocrystals, pharmaceutical compositions thereof, and methods of treatment involving same ⤷  Sign Up
Mexico 2016000360 COMPUESTOS TERAPEUTICAMENTE ACTIVOS Y SUS METODOS DE USO. (THERAPEUTICALLY ACTIVE COMPOUNDS AND THEIR METHODS OF USE.) ⤷  Sign Up
Eurasian Patent Organization 030199 ТЕРАПЕВТИЧЕСКИ АКТИВНЫЕ СОЕДИНЕНИЯ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (THERAPEUTICALLY ACTIVE COMPOUNDS AND METHODS OF USE THEREOF) ⤷  Sign Up
Canada 3081535 COCRISTAUX, COMPOSITIONS PHARMACEUTIQUES DE CEUX-CI, ET METHODES DE TRAITEMENT LES IMPLIQUANT (COCRYSTALS, PHARMACEUTICAL COMPOSITIONS THEREOF, AND METHODS OF TREATMENT INVOLVING SAME) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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